Incidents of coccidioidomycosis (Valley fever), a fungal infection caused by Coccidioides immitis and Coccidioides posadasii, are on the rise in the Southwestern United States and elsewhere. While most cases are mild, some individuals develop severe disease with limited treatment options. In response, NIAID invites community and stakeholder feedback on a strategic plan to advance research and development of a vaccine for coccidioidomycosis through the Request for Information (RFI): Inviting Comments and Suggestions To Advance Research and Vaccine Development for Coccidioidomycosis (Valley Fever).
The strategic plan is structured around three research areas vital to vaccine development.
Strategic Priority 1: Understanding Coccidioides pathogenesis and host response
- Improve understanding of pathogenesis
- Expand understanding of the pathogen life cycle, including the role of host factors, physical and environmental factors that contribute to disease
- Determine the interaction of innate and adaptive immunity in response to infection
- Identify immune markers associated with reduced disease severity
- Improve genotypic and phenotypic characterization associated with adverse clinical outcomes, and host immunity
- Elucidate mechanisms of protective immunity versus those that ameliorate symptomatic disease
- Identify immunogens that elicit broad protection
- Determine impact of individual species on clinical outcomes
- Identify biomarkers that could inform disease progression and contribute to rapid diagnostics
- Define mechanisms and correlates of natural infection-induced protection
- Define mechanisms and correlates of vaccine-induced protection
Strategic Priority 2: Develop vaccine strategies to prevent coccidioidomycosis
- Advance new vaccine approaches into preclinical models that exploit emerging antigen design strategies, novel technologies, and/or platforms
- Support rational design of vaccines for coccidioidomycosis
- Test adjuvants and alternative delivery methods to enhance breadth and durability of immunity
- Understand the impact and safety of vaccination in previously infected individuals
Strategic Priority 3: Develop Tools and Resources
- Develop rapid, point-of-care diagnostics
- Develop cell culture and animal models that reflect human disease for preclinical use
- Leverage and expand clinical capacity to test vaccine candidates, particularly for high-risk and underserved populations
- Encourage collaborations between researchers and vaccine developers
Information Requested
NIAID seeks comments from the scientific community and the general public regarding any of the following topics in Coccidioides research:
- Significant research gaps or barriers not identified in the above strategic priorities
- Identification of items most likely to facilitate vaccine development
- Necessary resources critical to advancing research in the three strategic areas
- Emerging scientific advances or techniques that may accelerate research related to the three priorities
- Approaches to increase marketability of a vaccine and facilitate collaborations with industry
How To Submit a Response
Submit comments through the Request for Information (RFI): Inviting Comments and Suggestions To Advance Research and Vaccine Development for Coccidioidomycosis (Valley Fever).
Do not include any confidential or sensitive information in your response.
Responses are due by 11:59 p.m. Eastern Time on April 5, 2022.